Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation.

The regulatory agencies all over the world have defined the pathway and regulations for the approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for the approval of biosimilars. In this view, there are no defined regulations for the approval of complex generics, also known as non-biological complex drugs (NBCDs).